BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNX VASCULAR CLOSURE DEVICE

    MDR report key: 927713 · Received October 16, 2007

    Report

    Report Number
    3004939290-2007-00010
    Event Type
    Malfunction
    Date Received
    October 16, 2007
    Date of Event
    September 17, 2007
    Report Date
    October 16, 2007
    Manufacturer
    ACCESS CLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BALLOON DETACHMENT CONFIRMED. THE SEVERE DEFORMATION ON THE INSIDE OF THE ADVANCER TIP AND THE CURVED SHAFT AND CORE WIRE INDICATES THAT AN UNUSUAL NON-COAXIAL LOAD WAS APPLIED TO THE CATHETER DURING THE PROCEDURE, MOST LIKELY WITH THE TIP OF THE ADVANCED TUBE. THE BALLOON DETACHMENT WAS REPLICATED IN BENCH TESTING BY INCOMPLETELY DEFLATING THE BALLOON AND MISALIGNING THE ADVANCER TUBE RELATIVE TO THE PUNCTURE TRACT PRIOR TO WITHDRAWING THE CATHETER WITH AN IMPULSE RETRACTION FORCE. THE BALLOON DETACHMENT COULD NOT BE REPRODUCED WHEN THE ADVANCED TUBE WAS CORRECTLY ALIGNED AND THE BALLOON WAS FULLY DEFLATED PRIOR TO WITHDRAWAL. NO ISSUES WERE NOTED DURING THE LOT HISTORY REVIEW THAT SUGGESTS THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT.

    Description of Event or Problem · 1

    A MALE UNDERWENT AN UNCOMPLICATED CORONARY INTERVENTION IN 2007. LASTING APPROXIMATELY 35 MINUTES. THE MYNX DEVICE WAS PREPPED FOR USE ACCORDING TO IFU. THE PHYSICIAN REPORTED THAT POST MYNX DEPLOYMENT, RESISTANCE WAS FELT WHILE REMOVING THE DEVICE FROM THE ADVANCER TUBE. HE THEN ATTEMPTED TO REMOVE THE DEVICE AS A WHOLE, HOWEVER, RESISTANCE WAS STILL FELT. HE PROCEEDED TO RETRACT THE ADVANCER TUBE AND REMOVED THE DEVICE BY THE EXPOSED WIRE AT SKIN LEVEL, AND HEMOSTASIS WAS SUCCESSFULLY ACHIEVED. IT WAS THEN NOTED THAT THE BALLOON WAS DETACHED FROM THE DEVICE. THE PHYSICIAN PERFORMED A CONTRALATERAL STICK TO DO A PERIPHERAL ANGIO IN WHICH NO FLOW DISTURBANCES OR ANY COMPLICATIONS WERE NOTED. PATIENT WAS ASYMPTOMATIC, BP AND PEDAL PULSES NORMAL, LEG COLOR AND TEMPERATURE NORMAL. DOPPLER ULTRASOUND THE NEXT DAY WAS ALSO REPORTEDLY UNREMARKABLE. NO FURTHER DIAGNOSTIC OR THERAPEUTIC INTERVENTIONS WERE ORDERED. PT WAS DISCHARGED THE SAME DAY PER STANDARD HOSPITAL PROCEDURE WITHOUT FURTHER INCIDENT, AND AT THE TIME OF THIS REPORT, THERE HAS BEEN NO REPORT OF CLINICAL SEQUALE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYNX VASCULAR CLOSURE DEVICE MYNX VASCLURE CLOSURE DVICE MGB ACCESS CLOSURE, INC. MX6700 F0721106

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR PRE-PROCEDURE MEDS, NOT DOCUMENTED| PERI-PROCEDURE MEDS, IIB/IIIE INHIBITOR